Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT06315738 · ClinicalTrials.gov registry record · Phase 1

Study to Assess the Safety, Tolerability, and Preliminary Efficacy of ST266 in Infants With Necrotizing Enterocolitis

A Phase 1 study of Necrotizing Enterocolitis, sponsored by Noveome Biotherapeutics, formerly Stemnion.

Recruiting
Registry status
Phase 1
Development phase
36
Enrollment target
7
Study locations

NCT06315738 is a Phase 1 study of Necrotizing Enterocolitis that is actively recruiting participants, run by Noveome Biotherapeutics, formerly Stemnion. The registered enrollment target is 36 participants, below the 311-participant average among 14 other Necrotizing Enterocolitis trials with a reported enrollment target (88% lower). The trial reports 7 study locations across 6 states.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT06315738, a Phase 1 study of Necrotizing Enterocolitis, is actively recruiting participants, sponsored by Noveome Biotherapeutics, formerly Stemnion.

RECRUITING
Registry status
Phase 1
Development phase
36 participants
Enrollment target
7
Study locations

Study Summary

The primary objective of this study is to determine the safety and tolerability of two dose levels (0.5 mL/kg and 1.0 mL/kg) of once daily (QD) via IV route of administration of ST266 in treating patients with Bell's stage IIA or higher medical NEC by incidence of treatment emergent adverse events (TEAEs) and SAEs, with a secondary objective to assess preliminary efficacy of the same two dose levels (0.5 mL/kg and 1.0 mL/kg) of QD via IV route of administration of ST266 in treating patients with Bell's stage IIA or higher medical NEC.

Conditions Studied

Necrotizing Enterocolitis

Interventions

  • BIOLOGICAL ST266

Study Locations (7)

Florida

  • Orlando Health, Inc. Winnie Palmer Hospital for Women and Babies - Orlando
  • BayCare Health System-St. Joseph's Women's Hospital - Tampa

Connecticut

  • Yale-New Haven Hospital - New Haven

Illinois

  • NorthShore University-Evanston Hospital - Evanston

North Carolina

  • Duke University Medical Center (DUMC) - Durham

Oklahoma

  • Oklahoma Children's Hospital - Oklahoma City

Pennsylvania

  • University of Pittsburgh Medical Center Magee Womens Hospital - Pittsburgh

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 2024-08-19
Est. Completion 2029-11
Phase Phase 1

Sponsor

Noveome Biotherapeutics, formerly Stemnion

12 total trials

Interested in This Trial?

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06315738

The ClinicalTrials.gov registry entry for NCT06315738 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 311-participant average among 14 other Necrotizing Enterocolitis trials with a reported enrollment target (88% lower). The listed sponsor is Noveome Biotherapeutics, formerly Stemnion, which has 12 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Necrotizing Enterocolitis appearing as the primary indexed condition, and to 1 intervention - of which ST266 is the first listed.

NCT06315738 reports 7 study locations spanning 6 distinct geographic areas - top geographies include Florida, Connecticut, Illinois.

Frequently Asked Questions

What is clinical trial NCT06315738 about?

NCT06315738 is a clinical study titled "Study to Assess the Safety, Tolerability, and Preliminary Efficacy of ST266 in Infants With Necrotizing Enterocolitis". The primary objective of this study is to determine the safety and tolerability of two dose levels (0.5 mL/kg and 1.0 mL/kg) of once daily (QD) via IV route of administration of ST266 in treating patients with Bell's stage IIA or higher medical NEC by incidence of treatment emergent adverse events (...

What is the current status of trial NCT06315738?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2024-08-19. Estimated completion is 2029-11.

What conditions does trial NCT06315738 study?

This clinical trial studies the following conditions: Necrotizing Enterocolitis.

What interventions are being tested in trial NCT06315738?

The interventions under investigation include: ST266 (BIOLOGICAL).

Who is sponsoring clinical trial NCT06315738?

This trial is sponsored by Noveome Biotherapeutics, formerly Stemnion, which has 12 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06315738 being conducted?

This trial has 7 study locations across Connecticut, Florida, Illinois, North Carolina, Oklahoma. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Necrotizing Enterocolitis

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Explore more on PlainTrial

Necrotizing Enterocolitis

All registered trials for this condition

Connecticut

All trials with a study site in Connecticut

Recruiting now

Find trials open to new participants near you

Rankings

Top sponsors, conditions, and phases

Read our methodology - how this data is sourced, computed, and verified.

Related

Browse all → | Rankings →
Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.